The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.
Take action
Contact the company
📍Recalling firmMedline Industries IncThree Lakes Drive · Northfield, IL 60093
“Medline Primary Warmer Pack Recall: Unsafe Aluminum Levels in Infusion Sets.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67957-medline-primary-warmer-pack-recall-unsafe-aluminum-levels-in-infusion. Based on FDA recall #Z-2066-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2066-2019%22&limit=1).
The FDA announced on May 3, 2019, that Medline Industries Inc. recalled the Medline Primary Warmer Pack, Product No. DYNJ52510A, due to potential unsafe aluminum levels and incomplete occlusion hazards. The agency classified this voluntary Class I recall as terminated.
The recalled Vyaire enFlow disposable cartridge contains a heating element that may elute unsafe aluminum levels into the infusate. Additionally, the included BD Alaris Pump Infusion Set may cause incomplete occlusion due to variations in tubing wall thickness, potentially leading to serious adverse events for patients.
Context
GovInfoNow's records show Medline Industries Inc has issued 48 other recalls since September 25, 2015. Recent brand recalls include a July 21, 2022 recall of a Chest Tube Kit for non-sterile tape in a sterile component and an October 27, 2021 Neuro Convenience Kit recall involving an expired NaCl bag. Other recent recalls of similar products include B Braun ULTRASITE IV Sets (October 29, 2025), B Braun Blood Administration Sets (October 29, 2025), and B Braun Medical Blood Set (October 29, 2025), all citing a risk of medication backflow.
How to tell if you have this one
Look for Medline Primary Warmer Packs with Product Number DYNJ52510A. The affected cartridges were sold in specific lots from 2018 to 2019.
Brand
Medline
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Identify the lot number on the warmer pack, which may be found on the packaging or label.
Contact Medline for Replacement
Reach out to Medline directly to request a replacement or alternative solution for the affected warmer packs.
Where it went and when
Where it was distributed
Distributed in Illinois.
Listed by the agency
Not listed
FDA distribution: “One distributor located in Illinois.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2066-2019 (May 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2066-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.